Rulemaking History for OTC Ophthalmic Drug Products View by Topic
Final Monograph (21 CFR part
349):
Ophthalmic Drug Products for Over-the-Counter Human Use
[PDF]
[HTML] |
Date |
Federal
Register Citation |
Description |
3/6/1979 |
44FR12270
|
Notice:
Classifies contact lens solution is
device (not drug) |
5/6/1980 |
45FR30002 |
Advance
Notice of Proposed Rulemaking |
7/22/1980 |
45FR48920 |
Correction: Advance
Notice of Proposed Rulemaking
|
6/28/1983 |
48FR29788 |
Tentative
Final Monograph |
7/19/1983 |
48FR32837 |
Correction: Tentative
Final Monograph
|
3/4/1988 |
53FR6997
|
Reopening
of Administrative Record: Yellow mercuric oxide
(anti-infective) excluded from final monograph |
3/4/1988 |
53FR7076
|
Final
Monograph |
4/21/1988 |
53FR13217
[HTML] |
Correction: Final
Monograph
|
12/5/1989 |
54FR50240
[HTML] |
Request
for Data: Emergency first aid eyewashes |
2/19/2003 |
68FR7951
[HTML] |
Proposed
Rule: Emergency first aid eyewashes |
2/19/2003 |
68FR7919
[HTML] |
Technical
Amendment: Incorporates emergency
first aid eyewashes in monograph |
6/3/2003 |
68FR32981
[HTML] |
Technical
Amendment: Revises "hydroxypropyl methylcellulose" to
"hypromellose" |
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Date updated: December 28, 2006; April 12, 2007 |